The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase

Non-Small-Cell Lung Cancer Clinical Trial

— EVALUATE  

Official title:

The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02755337
• Other study ID #: Dr. Soetomo General Hospital
• Status: Recruiting
• Phase: N/A
• First received: April 25, 2016
• Last updated: April 27, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Dr. Soetomo General Hospital
• Contact: Laksmi Wulandari, MD, PhD
• Phone: +628123019591
• Email: laksmigts[@]yahoo.co.id
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General Hospital, Surabaya, Indonesia.

Description:

Primary Objective: To determine the efficacy of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Secondary Objective: To evaluate the subjective response of NSCLC patients harboring a positive EGFR mutation who treated with Gefitinib.

Safety Objective: To evaluate the safety and tolerability of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• NSCLC based on histopathologic examination

• Adenocarcinoma and/or nonadenocarcinoma based on histology examination

• Clinical stadium stage IIIB and IV

• Age 16-70 years old

• Received gefitinib as therapy

• At least completed 2 (two) data sets of RECIST 1.1 evaluations during the study period from January 2013 until July 2015

Exclusion Criteria:

• Missing data of any variables of the treatment outcomes in the medical record

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Locations

Country	Name	City	State
Indonesia	Dr. Soetomo General Hospital	Surabaya	East Java

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Soetomo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS (Progression Free Survival)	Progression Free Survival (PFS) as defined by RECIST 1.1 or attending physician's clinical judgement of clinical progression state	through study completion, in average of 1 year	No
Primary	Overall Survival (OS)	Overall Survival (OS) as defined by the date of death certificate given by the attending physician or by other government officials	through study completion, in average of 1 year	No